High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

Rotator Cuff Tendinosis Clinical Trial

Official title:

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483517
• Other study ID #: A202205076
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Tri-Service General Hospital
• Contact: Liang cheng Chen, MD, MS
• Phone: 886-2-87923311
• Email: clctsgh[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy

Description:

Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain. High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz~300MHz) is very different from traditional PEMF. Magnetic field about 50~150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. age between 20 to 75 years old

2. persistent shoulder pain for at least 3 months and pain VAS score >=5

3. positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests

4. confirmed rotator cuff tendinopathy by ultrasonography or MRI

Exclusion Criteria:

1. complete or full-thickness tear of rotator cuff found by ultrasonography or MRI

2. previous shoulder surgery

3. previous history of severe trauma in shoulder

4. cervical radiculopathy related shoulder pain or referred pain

5. other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear

6. present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout

7. previous treatment with articular or subacromial steroid injections within the last 3 months

8. cognitive impairment with loss of ability to sign the agreement and receive rehabilitation

9. pregnancy or lactating women

10. has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

Device:
• High energy density pulse electromagnetic field
The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.
• sham High energy density pulse electromagnetic field
The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

Behavioral:
• physiotherapy
Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

Locations

Country	Name	City	State
Taiwan	Tri-service general hospital	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain Visual Analogue Scale(VAS)	The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.	the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary	Change in Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings (ADLs) requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80.A higher score shows more disability.	the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary	Blood test	Perform blood test to analysis the change of interleukin-1ß, interleukin-6, interleukin-10	change from baseline to 1 month
Secondary	Blood test	Perform blood test to analysis the change of transforming growth factor-ß(TGF-ß)	change from baseline to 1 month